Clinical Operations

• Oversee strategy and implementation of all sponsored clinical trials within Arvinas’ development pipeline.
• Drive a pre-clinical study into Phase I and through clinical development.
• Ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards.
• Ensure that appropriate company infrastructure and quality systems are in place to support all clinical trials.
• Lead execution of clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Arvinas SOPs.
• The Director will report to the Executive Director, Clinical Operations and can work from a remote location within the US.
• Build department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Ensure external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Builds collaborative relationships with key stakeholders including Medical, Regulatory Affairs, CMC/Supply Chain, IT, Legal, Finance departments, and project teams as needed to support clinical programs.
• Collaborate with KOLs for feedback on study protocols and development plans.
• Implement and lead a Clinical Development Team
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Review and Clean Global Clinical Study data.
• Prepare IB and DSUR Documentation.
• Prepare Clinical Documentation.
• Develop protocol paradigm to anticipate protocol execution and preparation of investigators.

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